Hope S. Rugo, MD, on Comparing CDK4/6 Inhibitors in HR+/HER2– Advanced Breast Cancer

Hope S. Rugo, MD, director of Breast Oncology and Clinical Trials Education and professor of medicine in the Division of Hematology and Oncology at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, spoke with CancerNetwork® at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting about a matching-adjusted indirect comparison (MAIC) study analyzing data for ribociclib (Kisqali) plus an aromatase inhibitor (AI) vs abemaciclib (Verzenio) plus AI for patients with hormone receptor–positive, HER2-negative advanced breast cancer. She mentioned that quality of life (QOL) was a large focus of study, specifically the management of adverse effects.¹

Transcript:

This is an interesting analysis that is discussed in a poster discussion session at ASCO 2022. It’s called a MAIC analysis, and you do modeling to try and match patients from different trials. Our rule is not to do cross-trial comparisons because the patients are different. We saw that with the [phase 3] PALOMA-2 trial [NCT01740427] survival data that there was a population included who’d had a short disease-free interval that wasn’t included in any other study. It makes the results hard to compare. In this MAIC analysis, you try and account for some of the differences. You match the patients, and both trials used similar quality of life tools so you could compare. PALOMA-2 wasn’t included in that analysis because they used a different quality of life tool, so you couldn’t do a comparison.

In the MAIC analysis, what we were able to look at was what QOL factors made a difference for patients, how they tolerated treatment, and what the impact was. It was interesting that diarrhea was a big issue, that’s the bottom line. You don’t feel neutropenia, patients don’t mind so much coming back for different blood draws. They do have fatigue and it’s a big issue for them. Diarrhea seems to be a more invasive and a difficult symptom to manage. There was another survey that was presented at the San Antonio [Breast Cancer Symposium] last year by Fatima Cardoso, MD, that looked at what patients ranked as the symptoms they [suffered from the most] and diarrhea was on top.² It can be unpredictable. Then there is a little bit of a yo-yo with constipation and diarrhea. There’s [a lot of] urgency there. We might have guessed that that would have been the case. It’s nice to have some validation and comparison where you could see that if you had a choice of different drugs you might want to choose based on the individual patient’s needs and history. For example, you wouldn’t give a patient who had colitis a drug that caused a lot of diarrhea, so that would be the abemaciclib. If a patient is neutropenic all the time, you might not want to give them ribociclib. These data help us analyze trials and maximize our ability to treat the disease effectively, but also maintain or at least manage the patient’s QOL, which is such an important end point. This analysis is very helpful for us to see how what we already believed is assessed and discussed by patients.

References

1. Rugo HS, O’Shaughnessy J, Jhaveri KL, et al. Quality of life (QOL) with ribociclib (RIB) plus aromatase inhibitor (AI) versus abemaciclib (ABE) plus AI as first-line (1L) treatment (tx) of hormone receptor-positive/human epidermal growth factor receptor–negative (HR+/HER2−) advanced breast cancer (ABC), assessed via matching-adjusted indirect comparison (MAIC). J Clin Oncol. 2022;40(suppl 16):1015. doi: 10.1200/JCO.2022.40.16_suppl.1015
2. Cardoso F, Rihani J, Aubel D, et al. Assessment of quality of life in patients with advanced breast cancer in clinical practice: a real-world multi-country survey. Cancer Res. 2022;82(suppl 4):P4-12-03. doi:10.1158/1538-7445.SABCS21-P4-12-03